Improved time to treatment failure and survival in ibrutinib-treated malignancies with a pharmaceutical care program: an observational cohort study.
Adenine
/ analogs & derivatives
Aged
Aged, 80 and over
Cohort Studies
Efficiency, Organizational
Female
Humans
Male
Middle Aged
Neoplasms
/ drug therapy
Pharmaceutical Services
/ organization & administration
Pharmacists
/ organization & administration
Piperidines
Pyrazoles
/ therapeutic use
Pyrimidines
/ therapeutic use
Quality Improvement
Survival Analysis
Time Factors
Time-to-Treatment
/ organization & administration
Treatment Failure
Education
Ibrutinib
Leukemia
Lymphoma
Pharmacist
Survival
Journal
Annals of hematology
ISSN: 1432-0584
Titre abrégé: Ann Hematol
Pays: Germany
ID NLM: 9107334
Informations de publication
Date de publication:
Jul 2020
Jul 2020
Historique:
received:
31
01
2020
accepted:
15
04
2020
pubmed:
3
6
2020
medline:
24
7
2020
entrez:
3
6
2020
Statut:
ppublish
Résumé
Ibrutinib treatment has been shown to increase survival in patients with B cell malignancies. Real-life data suggest a large part of discontinuations are due to toxicities, impairing ibrutinib efficacy. We aimed to assess the impact of a pharmaceutical care program on the efficacy and safety of ibrutinib. This single-center, cohort, observational study enrolled patients with B cell malignancies. Patients were either assigned to the program or to receive usual care, based on physician decision. The program was conducted by clinical pharmacists specializing in oncology and included patient education for management of toxicities, adherence monitoring, interventions to reduce drug-drug interactions, and follow-up of transition from hospital to community. Between February 2014 and May 2017, we enrolled 155 patients, including 42 (27%) who were allocated to the program group and 113 (73%) to the usual care group. The effect of the program was beneficial in terms of time to treatment failure (p = 0.0005). The 30-month progression-free and overall survivals were significantly superior in the program group (respectively p = 0.002 and p = 0.004). Grade 3 or higher adverse events occurred more frequently for patients in the usual care group (15%) than program group (8%). A pharmaceutical care program provides a personalized environment for outpatient monitoring and control of the key risks associated with oral anticancer agents. This study shows evidence that management of ibrutinib treatment by clinical pharmacists results in significant improvement in survival and better tolerance than usual care.
Identifiants
pubmed: 32483668
doi: 10.1007/s00277-020-04045-y
pii: 10.1007/s00277-020-04045-y
pmc: PMC7316844
doi:
Substances chimiques
Piperidines
0
Pyrazoles
0
Pyrimidines
0
ibrutinib
1X70OSD4VX
Adenine
JAC85A2161
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1615-1625Références
Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, Bairey O, Hillmen P, Bartlett NL, Li J, Simpson D, Grosicki S, Devereux S, McCarthy H, Coutre S, Quach H, Gaidano G, Maslyak Z, Stevens DA, Janssens A, Offner F, Mayer J, O'Dwyer M, Hellmann A, Schuh A, Siddiqi T, Polliack A, Tam CS, Suri D, Cheng M, Clow F, Styles L, James DF, Kipps TJ, RESONATE-2 Investigators. (2015) Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med 373: 2425—2437
Treon SP, Tripsas CK, Meid K, Warren D, Varma G, Green R, Argyropoulos KV, Yang G, Cao Y, Xu L, Patterson CJ, Rodig S, Zehnder JL, Aster JC, Harris NL, Kanan S, Ghobrial I, Castillo JJ, Laubach JP, Hunter ZR, Salman Z, Li J, Cheng M, Clow F, Graef T, Palomba ML, Advani RH (2015) Ibrutinib in previously treated Waldenström’s macroglobulinemia. N Engl J Med 372:1430–1440
doi: 10.1056/NEJMoa1501548
Dreyling M, Jurczak W, Jerkeman M, Silva RS, Rusconi C, Trneny M, Offner F, Caballero D, Joao C, Witzens-Harig M, Hess G, Bence-Bruckler I, Cho SG, Bothos J, Goldberg JD, Enny C, Traina S, Balasubramanian S, Bandyopadhyay N, Sun S, Vermeulen J, Rizo A, Rule S (2016) Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 387:770–778
doi: 10.1016/S0140-6736(15)00667-4
Byrd JC, Brown JR, O’Brien S et al (2014) Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med 371:213–223
doi: 10.1056/NEJMoa1400376
Maddocks KJ, Ruppert AS, Lozanski G, Heerema NA, Zhao W, Abruzzo L, Lozanski A, Davis M, Gordon A, Smith LL, Mantel R, Jones JA, Flynn JM, Jaglowski SM, Andritsos LA, Awan F, Blum KA, Grever MR, Johnson AJ, Byrd JC, Woyach JA (2015) Etiology of ibrutinib therapy discontinuation and outcomes in patients with chronic lymphocytic leukemia. JAMA Oncol. 1:80–87
doi: 10.1001/jamaoncol.2014.218
Gustine JN, Meid K, Dubeau T, Severns P, Hunter ZR, Guang Y, Xu L, Treon SP, Castillo JJ (2018) Ibrutinib discontinuation in Waldenström macroglobulinemia: etiologies, outcomes, and IgM rebound. Am J Hematol 93:511–517
doi: 10.1002/ajh.25023
Mato AR, Hill BT, Lamanna N, Barr PM, Ujjani CS, Brander DM, Howlett C, Skarbnik AP, Cheson BD, Zent CS, Pu JJ, Kiselev P, Foon K, Lenhart J, Henick Bachow S, Winter AM, Cruz AL, Claxton DF, Goy A, Daniel C, Isaac K, Kennard KH, Timlin C, Fanning M, Gashonia L, Yacur M, Svoboda J, Schuster SJ, Nabhan C (2017) Optimal sequencing of ibrutinib, idelalisib, and venetoclax in chronic lymphocytic leukemia: results from a multi-center study of 683 patients. Ann Oncol 28:1050–1056
doi: 10.1093/annonc/mdx031
Bassan F, Peter F, Houbre B, Brennstuhl MJ, Costantini M, Speyer E, Tarquinio C (2014) Adherence to oral antineoplastic agents by cancer patients: definition and literature review. Eur J Cancer Care 23:22–35
doi: 10.1111/ecc.12124
Barr PM, Brown JR, Hillmen P, O'Brien S, Barrientos JC, Reddy NM, Coutre S, Mulligan SP, Jaeger U, Furman RR, Cymbalista F, Montillo M, Dearden C, Robak T, Moreno C, Pagel JM, Burger JA, Suzuki S, Sukbuntherng J, Cole G, James DF, Byrd JC (2017) Impact of ibrutinib dose adherence on therapeutic efficacy in patients with previously treated CLL/SLL. Blood. 129:2612–2615
doi: 10.1182/blood-2016-12-737346
Ahn IE, Basumallik N, Tian X, Soto SJ, Wiestner A (2019) Clinically-indicated ibrutinib dose interruptions and reductions do not compromise long-term outcomes in CLL. Blood. 133:2452–2455
doi: 10.1182/blood.2019896688
de Zwart L, Snoeys J, De Jong J, Sukbuntherng J, Mannaert E, Monshouwer M (2016) Ibrutinib dosing strategies based on interaction potential of CYP3A4 perpetrators using physiologically based pharmacokinetic modeling. Clin Pharmacol Ther 100:548–557
doi: 10.1002/cpt.419
Finnes HD, Chaffee KG, Call TG, Ding W, Kenderian SS, Bowen DA, Conte M, McCullough KB, Merten JA, Bartoo GT, Smith MD, Leis J, Chanan-Khan A, Schwager SM, Slager SL, Kay NE, Shanafelt TD, Parikh SA (2017) Pharmacovigilance during ibrutinib therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in routine clinical practice. Leuk Lymphoma 58:1376–1383
doi: 10.1080/10428194.2016.1251592
Zerillo JA, Goldenberg BA, Kotecha RR, Tewari AK, Jacobson JO, Krzyzanowska MK (2018) Interventions to improve oral chemotherapy safety and quality: a systematic review. JAMA Oncol 4:105–117
doi: 10.1001/jamaoncol.2017.0625
Van Leeuwen RWF, Brundel DHS, Neef C et al (2013) Prevalence of potential drug-drug interactions in cancer patients treated with oral anticancer drugs. Br J Cancer 108:1071–1078
doi: 10.1038/bjc.2013.48
Austin PC (2014) The use of propensity score methods with survival or time-to-event outcomes: reporting measures of effect similar to those used in randomized experiments. Stat Med 33:1242–1258
doi: 10.1002/sim.5984
Little RJ, Rubin DB (2000) Causal effects in clinical and epidemiological studies via potential outcomes: concepts and analytical approaches. Annu Rev Public Health 21:121–145
doi: 10.1146/annurev.publhealth.21.1.121
Franklin JM, Rassen JA, Ackermann D, Bartels DB, Schneeweiss S (2014) Metrics for covariate balance in cohort studies of causal effects. Stat Med 33:1685–1699
doi: 10.1002/sim.6058
Gayat E, Resche-Rigon M, Mary J-Y, Porcher R (2012) Propensity score applied to survival data analysis through proportional hazards models: a Monte Carlo study. Pharm Stat 11:222–229
doi: 10.1002/pst.537
Leyrat C, Seaman SR, White IR, Douglas I, Smeeth L, Kim J, Resche-Rigon M, Carpenter JR, Williamson EJ (2019) Propensity score analysis with partially observed covariates: how should multiple imputation be used? Stat Methods Med Res 28:3–19
doi: 10.1177/0962280217713032
Neuss MN, Polovich M, McNiff K et al (2013) 2013 Updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and Management of Oral Chemotherapy. J Oncol Pract 9:5s–13s
doi: 10.1200/JOP.2013.000874
Segal EM, Bates J, Fleszar SL et al (2019) Demonstrating the value of the oncology pharmacist within the healthcare team. J Oncol Pharm Pract 25:1945–1967
doi: 10.1177/1078155219859424
Noens L, van Lierde M-A, De Bock R et al (2009) Prevalence, determinants, and outcomes of nonadherence to imatinib therapy in patients with chronic myeloid leukemia: the ADAGIO study. Blood. 113:5401–5411
doi: 10.1182/blood-2008-12-196543
Mislang AR, Wildes TM, Kanesvaran R, Baldini C, Holmes HM, Nightingale G, Coolbrandt A, Biganzoli L (2017) Adherence to oral cancer therapy in older adults: the International Society of Geriatric Oncology (SIOG) taskforce recommendations. Cancer Treat Rev 57:58–66
doi: 10.1016/j.ctrv.2017.05.002
Molassiotis A, Brearley S, Saunders M, Craven O, Wardley A, Farrell C, Swindell R, Todd C, Luker K (2009) Effectiveness of a home care nursing program in the symptom management of patients with colorectal and breast cancer receiving oral chemotherapy: a randomized, controlled trial. J Clin Oncol 27:6191–6198
doi: 10.1200/JCO.2008.20.6755
de Weerdt I, Koopmans SM, Kater AP, van Gelder M (2017) Incidence and management of toxicity associated with ibrutinib and idelalisib: a practical approach. Haematologica. 102:1629–1639
doi: 10.3324/haematol.2017.164103
Lipsky AH, Farooqui MZH, Tian X, Martyr S, Cullinane AM, Nghiem K, Sun C, Valdez J, Niemann CU, Herman SEM, Saba N, Soto S, Marti G, Uzel G, Holland SM, Lozier JN, Wiestner A (2015) Incidence and risk factors of bleeding-related adverse events in patients with chronic lymphocytic leukemia treated with ibrutinib. Haematologica. 100:1571–1578
doi: 10.3324/haematol.2015.126672
Chai KL, Rowan G, Seymour JF, Burbury K, Carney D, Tam CS (2017) Practical recommendations for the choice of anticoagulants in the management of patients with atrial fibrillation on ibrutinib. Leuk Lymphoma. 58:2811–2814
doi: 10.1080/10428194.2017.1315115
Ribed A, Romero-Jiménez RM, Escudero-Vilaplana V, Iglesias-Peinado I, Herranz-Alonso A, Codina C, Sanjurjo-Sáez M (2016) Pharmaceutical care program for onco-hematologic outpatients: safety, efficiency and patient satisfaction. Int J Clin Pharm 38:280–288
doi: 10.1007/s11096-015-0235-8
Mato AR, Nabhan C, Thompson MC, Lamanna N, Brander DM, Hill B, Howlett C, Skarbnik A, Cheson BD, Zent C, Pu J, Kiselev P, Goy A, Claxton D, Isaac K, Kennard KH, Timlin C, Landsburg D, Winter A, Nasta SD, Bachow SH, Schuster SJ, Dorsey C, Svoboda J, Barr P, Ujjani CS (2018) Toxicities and outcomes of 616 ibrutinib-treated patients in the United States: a real-world analysis. Haematologica. 103:874–879
doi: 10.3324/haematol.2017.182907
Winqvist M, Andersson P-O, Asklid A, Karlsson K, Karlsson C, Lauri B, Lundin J, Mattsson M, Norin S, Sandstedt A, Rosenquist R, Späth F, Hansson L, Österborg A, for the Swedish CLL Group (2019) Long-term real-world results of ibrutinib therapy in patients with relapsed or refractory chronic lymphocytic leukemia: 30-month follow up of the Swedish compassionate use cohort. Haematologica. 104:e208–e210
doi: 10.3324/haematol.2018.198820